Note: Descriptions are shown in the official language in which they were submitted.
CA 02764277 2012-01-16
JAW THRUST APPLIANCE
BACKGROUND OF THE INVENTION
FIELD OF THE INVENTION
The present invention relates to jaw and throat devices for the purposes of
maintaining an airway for medical procedures or for treating sleeping and
breathing
disorders. More specifically, the present device is an extra-oral headgear
that performs
a jaw thrust maneuver by forcing the mandible forward via a pair of thrust
pads
connected to a head-worn band and a plurality of supports that surround a
user's ears.
The jaw thrust maneuver is a medical airway management practice in which the
1o mandible (jaw) of a user is pushed forward to maintain an opening between
the external
environment and the user's lungs, and to further reduce the risk of
aspiration. Forcing
the mandible forward pushes the tongue forward and prevents it from occluding
the
entrance of the trachea by falling back into the pharyngeal air passage.
Several
circumstances and situations may require such a maneuver, including treatment
of
those individuals with sleeping or respiratory disorders, those undergoing a
medical
procedure and in a pharmacologically induced unconsciousness, and those in a
medical
emergency wherein the user is unconscious and in a supine position. Relaxation
of the
muscles of the pharynx, mandible and neck cause a collapsing inward and
narrowing of
the air passage from the mouth to the lungs, restricting the user's air supply
and
causing a potentially life threatening loss of oxygen (asphyxiation) or risk
of aspiration.
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The present invention is a new and novel means of performing a jaw thrust
maneuver on a patient or user, wherein a pair of thrust pads worn around ear
supports
that attach to an extra-oral headgear provide a means to comfortably and
conveniently
displace the jaw forward. The thrust pads place load on the angle of the
mandible from
the outside of a user's head, while the forward position of the jaw is
supported by the
ear supports that connect to the headgear encircling or otherwise attaching to
the user's
head. The present device is adapted to be utilized in several circumstances,
including
treatment of sleeping and breathing conditions, to emergency and critical
care. The
device can be deployed by a medical professional or be utilized by an
individual in the
comfort of his or her home for personal use. The following is a contemplated
list of such
treatments and scenarios in which the present device may function:
Sleeping disorders: for users with sleeping and respiratory disorders,
including
excessive snoring and sleep apnea, obstruction of the user's airway caused by
the
relaxation of the mouth and throat muscles can cause a significant decrease in
blood
oxygen levels (hypoxemia), as well as sleep deprivation induced by the
interrupted
sleep and reduced REM sleep for the user. These conditions can lead to serious
health
risks and complications, while at the same time affecting a user's partner via
the audible
nature of excessive snoring, which can disturb sleeping patterns and cause
daytime
drowsiness for both individuals as a result of a lack of adequate sleep. The
present
invention is intended to treat users having such disorders, including those
that snore
and/or have a history of diagnosed or undiagnosed sleep apnea. These
conditions are a
growing public health concern, as studies have shown that nearly 30% of our
population
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is obese, which is a major risk factor and cause of obstructive sleep apnea,
along with
age and aggravating factors such as smoking and diabetes. The present
invention is
provided to control the mandible of a user and prevent airway restrictions,
while
providing this control via a non-obtrusive and relatively convenient headgear
device that
does not otherwise affect a user's posture or comfort.
Medical procedures and anesthesia: obstructions of a patient's airway is
possible
during medical procedures wherein a user is asleep, either naturally or
pharmacologically-induced. A supine user under sedation or while in a comma
can
suffer similar airway restrictions caused by the relaxation of the mouth and
tongue
1o muscles, which can lead to an occlusion of the airway and a reduction in
oxygen levels.
Under sedation-type anesthesia, an anesthesiologist or assistant must be
vigilant and
actively maintain a patient's airway during a procedure. This can be
accomplished
through several different maneuvers, each one requiring the physician's hand
or hands
to be actively utilized, which can otherwise be utilized for patient
monitoring or
treatment. This limits the physician's ability to properly and fully manage
the patient care
while under anesthesia, particularly if a serious problem or complication
arises during
the procedure of which the physician is required to address and fix. A more
efficient
means of maintaining an airway is required, and one that does not require
constant
monitoring by a doctor, nurse or health professional. The present invention
provides
such a device, and one that does not overly engage and interfere with the
user's mouth
or head.
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Urgent and emergency care: first responders and physicians treating patients
with traumatic injuries encounter similar issues as those treating a sedated
patient,
wherein a patient's airway may be compromised while unconscious or while being
treated in a supine position. In emergency situations, airway restriction and
aspiration
are both a concern. Larger neck braces and head gear are generally utilized to
stabilize
the patient's airway and neck; however it may be desired to carry and utilize
a smaller
device that can accomplish a jaw thrust maneuver for emergency treatment and
prior to
cardiopulmonary resuscitation activities. The present invention can be
transported and
deployed in a number of environments with little to no storage requirements,
wherein its
so use facilitates an open airway and improved airway maintenance to prevent
asphyxiation and aspiration.
While snoring is a very common problem in the general population, of greater
concern is the incidence of obstructive sleep apnea, which is increasing
dramatically as
our population grows older and becomes more obese. Apnea is defined as the
cessation of oronasal airflow for at least 10 seconds or more. If this occurs
30 or more
times in a 7 hour sleep interval, it is defined as obstructive sleep apnea.
Most, if not all
patients with undiagnosed sleep apnea are not aware that they have it. In
fact, it has
been shown that up to 70% of patients presenting for medical procedures or
surgery
may have undiagnosed obstructive sleep apnea (OSA). People with OSA can have
daytime hypersomnolence, including easily falling asleep in un-stimulating
environments
(e.g. watching TV or driving). They can also have irritability, personality
changes,
headaches and/or depression. If left untreated, OSA can contribute to systemic
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hypertension, pulmonary hypertension, and heart failure leading to cor
pulmonale,
cardiac arrhythmias and congestive heart failure. These individuals are also
at a higher
risk for perioperative complications such as hypoxemia (low oxygen levels),
need for re-
intubation, hypertension, dysrhythmias and unplanned hospital admission.
Those who snore and/or who have obstructive sleep apnea (OSA) have
problems related with the soft tissue surrounding their airway, as well as
their tongue
collapsing into the posterior portion of their oropharynx. This restricts air
movement and
creates turbulent airflow that causes the sounds of snoring. When this
collapse is
severe (i.e. in OSA), complete airway closure occurs, preventing air flow and
leading to
1o dangerously low oxygen levels in the body. A significant contributing
factor to airway
collapse is the previously mentioned posterior movement of the tongue into the
posterior oropharynx. Therefore, in the vast majority of individuals, anterior
displacement of the tongue is usually all that is needed to help relieve
airway
obstruction and therefore maintain airway patency. The present invention
provides a
device for remedying this common condition.
DESCRIPTION OF THE PRIOR ART
The present invention is related to an external appliance that provides a jaw
thrust maneuver for patients suffering from certain conditions or in need of
medical
attention. Present devices utilized to treat such conditions, most
specifically sleep
apnea, including larger devices and breathing apparatuses to maintain active
breathing
during the night. Those patients in intensive care and those with extreme
cases of sleep
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apnea may utilize ventilators to maintain an open airway and to maintain
breathing. One
category of breathing masks includes CPAP or BiPAP masks that patients with
sleep
apnea wear at night. These devices maintain airway patency by forcing positive
air
pressure down a patient's airway. The major drawback associated with these
devices is
that they are uncomfortable to wear. Some patients complain that they are
suffocating
and they restrict the patient's body position while sleeping to a supine
position. Other
drawbacks are that these devices are expensive and can be noisy, disturbing
normal
sleep patterns and limiting a patient's willingness to utilize the device as a
means to
treat severe sleep apnea. Due to these problems, and the fact that patients
have to
1o undergo sleep studies and referrals from their family physicians to obtain
such devices,
many patients are noncompliant with using their CPAP or BiPAP machine.
Another category of devices utilized in the treatment of sleep apnea involves
intra-oral mandibular advancement devices. These devices move the jaw forward
by
intra-orally displacing the mandibular teeth forward (thereby creating an
under bite).
Even though this type of device solves some of the problems with the
CPAP/BiPAP
ventilator devices and aids in the treatment of sleep apnea (i.e. less
expensive, not
suffocating or noisy and doesn't require sleep studies or physician
referrals), these
device still have limitations. An intraoral device is an intrusive external
element within
the mouth that some individual may not tolerate sleeping. These devices can
stimulate
the gag reflex, making a person nauseated or vomit, and further are best
utilized by an
individual keeping his or her mouth closed and teeth clenched on/in the device
for
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proper position thereof. This type of device is not helpful for mouth
breathers, and is
found to generate high rates of non-compliance.
The present invention eliminates the suffocating action of intra-oral devices
and
the expense of CPAP or BiPAP machines, while being flexible to be utilized
individually
by a user or in medical treatment of patients and administered by trained
professionals.
The device allows a user to sleep in any position (supine, lateral or prone)
and
alleviates common drawbacks of devices utilized in the treatment of sleeping
disorders
and airway management for medical procedures and emergencies.
Several devices have been patented and disclosed in the prior art that relate
to
airway management and devices that perform a jaw thrust maneuver on a patient.
These devices have familiar design elements for the purposes of thrusting a
jaw forward
via the mandible angle; however the structure and spirit of the disclosed
devices differ
drastically from the present disclosure. Most devices in the art are bulky or
intrusive for
the user, and further not conducive for treating airway restrictions while
allowing the
user to sleep in any desired position. The present invention is ideally suited
for either
personal use, wherein normal sleeping positions and posture is not affected,
or
alternatively for medical procedure and patient care purposes wherein an
airway must
be actively monitored and protected from occlusion or aspiration. The
following devices
are considered the most relevant devices in the prior art to the present
disclosure.
U.S. Patent No. 5,682,632 to Cotroneo is one such device that discloses a jaw
thrust support device in the form of a contoured mold or cushion. The device
engages
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the angles of the mandible to accomplish a jaw thrust maneuver to open a
patient's
airway while in a prone position. The mold conforms to the patient and angles
his or her
head and neck while supporting the jaw and forcing it forward. The forward
position of
the jaw clear an airway by lifting the tongue from the patient's oropharynx
and
hypopharynx and lifting the epiglottis from in front of the patient's
laryngeal opening.
The Cotroneo device is a molded contour that the user lays against. The shape
of the
contour provides the jaw thrust maneuver, as opposed to a headgear device.
While
providing a novel means to open an otherwise redistricted airway, the Cotroneo
device
is best suited for use with unconscious patients or those being medically
treaded. The
1o present invention provides a device that can be utilized in a number of
circumstances
for the purposes of clearing user's airway, including for treatment of sleep
apnea,
excessive snoring or for ensuring an open airway while under anesthesia.
U.S. Patent No. 4,782,824 to Davies is another device that describes a neck-
worn device that maintains and open airway passage, comprising a lower portion
arranged to rest on the upper thorax and an upper portion having a means to
lifting and
thrusting forward the lower jaw. The posterior portion of the device prevents
backward
movement of the patient's jaw, positioning the jaw in such a way to prevent
airway
restrictions caused by the tongue falling into the airway or the pharynx
closing because
of the positioning of the jaw and throat. The Davies device is neck-worn, and
provides a
means to perform a jaw thrust maneuver on an unconscious or surgical patient
undergoing anesthesia. It is not well adapted for everyday use to correct
sleep disorders
and to be voluntarily worn by a user while asleep.
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U.S. Patent No. 4,597,738 to Sander describes an orthodontic device that is
adapted to thrust a lower jaw forward using internal thrust plate structures
within the
interior of a user's mouth. An upper and lower jaw thrust plate are provided,
which
connect to the front teeth region with activating rods and slideways,
respectively,
creating a displacement of the lower jaw with respect to the upper for
treatment of
supraocclusion or subocclusion, in which the lower jaw is excessively set back
from the
upper jaw. The Sander device is an orthodontic device adapted to be secured
within a
user's mouth to correct jaw alignment issues. It is not provided to maintain
an airway or
to treat breathing and sleep disorders, as provided by the present jaw thrust
device of
the present invention. The present invention is adapted to conform to the
exterior of a
user's head and operate to force the mandible forward to prevent airway
restrictions
while sleeping or undergoing anesthesia.
The structure and spirit of the forgoing prior art patents differ
significantly from
the present invention. These devices provide novel means for performing a jaw
thrust
maneuver, but fail to disclose a device that can be actively worn by a
conscious patient
to correct sleep disorders, while simultaneously offering the ability to be
utilized in
surgical procedures with an unconscious individual under anesthesia. The
aforementioned devices are considered relevant to the present disclosure, but
lack the
flexibility, comfort and convenience offered by the present device, which is
exteriorly
mounted and secured to a user's head to maintain a sufficient airway to treat
sleeping
and breathing disorders, and further to maintain an open airway during medical
procedures.
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U.S. Patent No. 7,951,102 to Gefen describes a cervical collar that maintains
an
airway of a trauma patient by immobilizing the patient's head and neck. The
collar
comprises a restricting frame and a jaw clasp to control the jaw of a patient
and connect
the jaw clasp to the restricting frame to prevent movement of the patient's
head, neck
and jaw. The jaw clasp performs a jaw thrust maneuver to maintain an open
airway,
while the clasp positioning is controlled by a plurality of movable mover
elements to
ensure secure fitment and restraint. The Gefen device is well suited for
trauma patients
and those being transported while requiring an open airway, but is less suited
for
individual use under normal circumstances. The present invention provides a
means to
thrust a patient's jaw forward and control an airway that offers minimal
interference with
the user's body. While providing a means to thrust a jaw forward, the Gefen
device is a
more intrusive device that fulfills a different need in the art than that of
the present
invention, which is minimally intrusive to a user's head and neck.
Finally, U.S. Patent No. 7,121,824 to Keles describes a facebow headgear
device to correct anterior open bites. The device is an extra-oral headgear
that creates
a frame on the user's face to correct oral conditions related to offset bites.
The device is
a head gear that operates with the jaw, but does not provide a means to thrust
the
mandible forward for the purposes of a jaw thrust maneuver or for correcting
various
sleep and breathing disorders. While providing a novel headgear that attends
to oral
alignment disorders, the Keles device fails to disclose a headgear that
fulfills the same
goals and needs of the present invention, which is an external, extra-oral
device that
CA 02764277 2012-01-16
forces the mandible forward to reduce restrictions on the pharynx and prevent
the
tongue from closing an airway while sleeping or while sedated.
It is therefore submitted that the present invention is substantially
divergent in
design elements from the prior art, and consequently it is clear that there is
a need in
the art for an improvement to existing extra-oral jaw thrust appliances. In
this regard the
instant invention substantially fulfills these needs.
SUMMARY OF THE INVENTION
In view of the foregoing disadvantages inherent in the known types of extra-
oral
jaw thrust appliances now present in the prior art, the present invention
provides a new
1o jaw thrust appliance wherein the same can be utilized for providing
convenience for the
user while treating sleeping and breathing disorders or for maintenance of a
patient's
airway by a medical professional.
It is therefore an object of the present invention to provide a new and
improved
extra-oral jaw thrust appliance device that has all of the advantages of the
prior art and
none of the disadvantages.
Another object of the present invention to provide an extra-oral jaw thrust
appliance that performs a jaw thrust maneuver on a user by displacing the
angle of the
mandible and forcing the jaw and tongue forward to maintain an open airway,
preventing the tongue from falling into the posterior oropharynx to prevent
asphyxiation
and aspiration.
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A further object of the present invention to provide an extra-oral jaw thrust
appliance that may be utilized by a user to treat sleeping and breathing
disorders, and
one that can be personally administered.
Yet another object of the present invention to provide an extra-oral jaw
thrust
appliance that can be utilized for airway management by medical professionals
during a
medical procedure or emergency.
A final object of the present invention to provide an extra-oral jaw thrust
appliance that is comfortable to wear and allows a user to sleep in any
position
desirable, including supine, lateral or prone.
Other objects, features and advantages of the present invention will become
apparent from the following detailed description taken in conjunction with the
accompanying drawings.
BRIEF DESCRIPTIONS OF THE DRAWINGS
Although the characteristic features of this invention will be particularly
pointed
out in the claims, the invention itself and manner in which it may be made and
used may
be better understood after a review of the following description, taken in
connection with
the accompanying drawings wherein like numeral annotations are provided
throughout.
FIG. 1 shows a frontal perspective view of the extra-oral jaw thrust appliance
of
the present invention.
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FIG. 2 shows a side perspective view of the present invention in a working
position on a user's head, forcing the mandible forward and performing a jaw
thrust
maneuver.
FIG. 3 shows an overhead view of the extra-oral jaw thrust appliance of the
present invention.
FIG. 4 shows a cross section view of a typical anatomy wherein a user's air
way
is restricted and oxygen cannot easily pass through.
FIG. 5 shows a cross section view of an anatomy of a user wearing the present
jaw thrust appliance, wherein the mandible is thrust forward to open the
user's airway.
1o DETAILED DESCRIPTION OF THE INVENTION
Reference is made herein to the attached drawings. Like reference numerals are
used throughout the drawings to depict like or similar elements of the extra-
oral jaw
thrust appliance. For the purposes of presenting a brief and clear description
of the
present invention, the preferred embodiment will be discussed as used for
opening and
maintaining an airway using an external headgear device that thrusts the
mandible
forward. The figures are intended for representative purposes only and should
not be
considered to be limiting in any respect.
Referring now to FIG. 1, there is shown a frontal perspective view of the
extra-
oral jaw thrust appliance of the present invention. The device comprises an
adjustable
head band 16 that encircles a user's head above their ears. Attached to the
head band
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16 and surrounding both ears are a plurality of supports arms 15 that form
inverted U-
shapes on either side of the user's head that originate from the head band 16
above the
ear to and wrap around the underside of each ear, attaching in a first and
second
position along the head band. Attached to the base of the inverted U-shape
support
arms 15 are a first and second jaw thruster 11. The jaw thrusters 11 comprise
an
adjustable mandible thruster pad 12 adapted to abut against the angle of the
mandible
and displace its natural position for the purposes of forcing the mandible
forward to
prevent airway restrictions. The pads 12 can be adjusted in a fore-aft
direction to create
a greater or lesser amount of mandible displacement, depending on user
geometry and
1o comfort.
In a particular embodiment, the jaw thruster comprises a pad 12 having a post
13
that slides along an adjustment sleeve 14 and lockable via a set screw or
similar
securement structure. The pad 12 position is controlled by first adjusting the
position of
the post 13 within the sleeve 14, and then further adjusting the position of
the thruster
11 by changing the length of each support arm 15. The support arm 15 length
can be
adjusted and locked into a static configuration to provide adequate structure
for which to
displace the mandible forward. Overall, the device acts as an external head
gear
without restricting the movement of the user's head or neck, or limiting the
sleeping
position of the user. It is desired to increase compliance with regard to head
gear use by
providing a comfortable device that provides minimal interference with the
user's nature
sleeping position or posture.
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Embodiments of the present device include any means to support the thrusters
11 in a position that provides connection to the mandible angle to displace
the mandible
forward. This includes a head band supporting inverted U-shape supports,
supports that
form around the backside of the user's ears in a similar fashion as
eyeglasses, and
finally a head band device that does fully encircles the head, but rather
pulls traction
against the user's forehead and supports the thrusters behind the mandible
angle. The
displacement of the mandible creates an under bite that prevents the tongue
from falling
back into the posterior portion of their oropharynx
Referring now to FIG. 2, there is shown a side perspective view of the extra-
oral
jaw thrust appliance of the present invention in a working position, secured
to a user's
head via a head band 16 and forcing the user's mandible from a first, natural
position 18
to a second, forward position 19. The device is secured to a user's head using
a head
band securement means 16, wherein a pair of jaw thrusters is positioned below
the
user's ears 17 and behind the angle of the mandible. The jaw pad 12 of the
thruster
places load on the mandible and displaces it into a forward position 19 while
the pad is
supported by a plurality of supports 15 that maintain the thrusters in a
static position
while in operation.
Referring now to FIG. 3, there is shown an overhead view of the present jaw
thrust appliance of the present invention. In an exemplary embodiment, the jaw
thrust
pads 12 of the present invention are supported by a pair of inverted U-shape
supports
that connect to a circumferential head band 16 that encircles the user's head.
The head
CA 02764277 2012-01-16
band adjustably attaches to the user's head and supports the pads behind the
mandible
while in a working position, forcing the jaw forward to prevent the tongue and
soft tissue
of the mouth to restrict air flow into the trachea and lungs. Maintaining this
airway is of
particular concern during both medical procedures and for those with sleeping
disorders, such as excessive snoring and sleep apnea.
For surgeries and medical procedures that are performed under sedation
anesthesia, a patient is given enough anesthetics to maintain spontaneous
breathing
but be unaware of the situation or surroundings. All too often, patients may
obstruct
their airway, generally by having the tongue fall back into the posterior
oropharynx,
1o which requires assistance by the anesthesiologist or nurse anesthetist to
maintain
airway patency. The second intended situation in which the present invention
is well
adapted applies to individuals sleeping at night who may voluntarily
administer sleeping
disorder remedies. Those individuals who snore at night or have problems with
sleep
apnea can benefit by wearing the disclosed extra-oral appliance to comfortably
and
effectively prevent collapsing of the user's airway, which is the cause of
such disorders.
It can be worn while sleeping to provide the same benefit as one under
anesthesia - for
maintaining a patent airway. This patency is provided in a "hands-free"
manner, wherein
the airway is maintained by pushing on the angle of the mandible to displace
it forward,
thereby moving the tongue forward with it and relieving the airway
obstruction. The
elements of the invention are provided to allow the device to be used in many
patient
positions (i.e. supine, lateral and prone) with minimal to no interference
therewith. This
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increases compliance and therefore increases the device's effectiveness as a
remedy
for such disorders or situations in which airway clearance must be diligently
monitored.
Referring now to FIG. 4 and FIG. 5, there are shown a two cross section views
of
a user's mouth while breathing. In FIG. 4, the natural state of a user having
a restricted
airway is shown. The jaw 19 is in a relaxed state, wherein the tongue 21 and
soft tissue
of the mouth is permitted to collapse the posterior oropharynx 23 airway while
the
nasopharynx 24 and passageway 24 therethrough is similarly collapsed, limiting
natural
breathing and causing a potentially dangerous condition that limits intake 20
of air into
the lungs. Shown in FIG. 5 is a cross section view of a user wearing the
disclosed extra-
oral jaw thrust appliance, wherein the mandible is forced into a forward
position 18. In
this position, the tongue 21 is prevented from collapsing or occluding the
oropharynx 23.
Normal, unobstructed breathing is permitted in this position, as the elements
of the
mouth are prevented from falling into a position that can restrict air flow
when in a
relaxed state, while under anesthesia or while sleeping naturally.
Overall, the present invention provides a new and improved means of
maintaining an open airway and treating sleeping disorders such as excessive
snoring
and sleep apnea. It is desired to disclose a pair of jaw thruster devices that
displace the
mandible forward via forward depression of the mandible angle. The thrusters
are
supported by an external, extra-oral head appliance that encircles the user's
head and
surrounds the user's ears. Load is transferred from the mandible, in its
forward position
as it attempts to return to its natural, relaxed position, to the jaw thruster
pad and to the
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thruster support, which is connected to the head gear supported around the
user's
head. The size, fit and comfort of the device can be adjusted in each element,
including
the head band diameter, thruster support lengths and fore-aft thruster pad
positioning.
It is submitted that the instant invention has been shown and described in
what is
considered to be the most practical and preferred embodiments. It is
recognized,
however, that departures may be made within the scope of the invention and
that
obvious modifications will occur to a person skilled in the art. With respect
to the above
description then, it is to be realized that the optimum dimensional
relationships for the
parts of the invention, to include variations in size, materials, shape, form,
function and
manner of operation, assembly and use, are deemed readily apparent and obvious
to
one skilled in the art, and all equivalent relationships to those illustrated
in the drawings
and described in the specification are intended to be encompassed by the
present
invention.
Therefore, the foregoing is considered as illustrative only of the principles
of the
invention. Further, since numerous modifications and changes will readily
occur to those
skilled in the art, it is not desired to limit the invention to the exact
construction and
operation shown and described, and accordingly, all suitable modifications and
equivalents may be resorted to, falling within the scope of the invention.
18
